MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT

MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT is an FDA 510(k)-cleared medical device (K131673) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2013. Regulation: 8.